Senior Regulatory Supervisor

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products.

Key Responsibilities

• Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices.
• Prepare and review regulatory documentation to ensure compliance with FDA regulations and standards.
• Advise product development teams on regulatory requirements and strategy throughout the product lifecycle.
• Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices.
• Interface with FDA and other regulatory authorities to respond to inquiries and resolve regulatory issues.
• Ensure timely submission of regulatory filings, meeting project deadlines and milestones.
• Support internal audits and inspections related to regulatory compliance.
• Review labeling and promotional materials to ensure compliance with regulatory requirements.
• Develop and implement strategies for regulatory approvals in international markets, as needed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Minimum of 5-7 years of regulatory affairs experience in the medical device industry.
• Proven experience in authoring and managing FDA 510(k) submissions. 510(k) number will be requested to verify.
• Strong understanding of FDA regulations, including 21 CFR Part 820, 21 CFR Part 807, and related guidance.
• Ability to interpret and apply regulatory requirements to complex technical issues.
• Excellent communication, organization, and problem-solving skills.
• Experience in preparing responses to FDA queries and managing interactions with regulatory authorities.
• Ability to work independently and collaboratively in a cross-functional team environment.

Preferred

• RAC (Regulatory Affairs Certification) or similar professional certification.
• Experience with international regulatory submissions (e.g., CE marking, Health Canada).